Component EngineerValidation (IQ / OQ / PQ)

Overview

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Experienced Component Engineer with strong expertise in equipment and process validation, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ). Proven ability to manage component selection, supplier coordination, and quality documentation to ensure compliance with FDA, ISO 13485, and GMP standards.

Responsibilities

• Component validation activities including creation and execution of IQ / OQ / PQ protocols and reports.
• Collaborate with cross-functional teams (QA, R&D, Manufacturing) to evaluate and qualify new components.
• Conduct risk assessments (FMEA) and support design and process changes.
• Coordinate with suppliers for part approval, PPAPs, and validation documentation.
• Ensure all validations meet regulatory compliance (21 CFR Part 820, EU MDR, ISO 14971).
• Support CAPA and non-conformance investigations related to component failures.
• Validation protocols (IQ, OQ, PQ).
• Component qualification and material review.
• Regulatory knowledge (FDA, ISO 13485, cGMP).
• Root cause analysis, CAPA.
• Supplier qualification and audits.

Qualifications / Seniority

Note : This description focuses on the role responsibilities and required qualifications. Related job postings and extraneous site content have been omitted to ensure clarity.

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